Page 98 - 《中国药房》2022年13期

·药物经济学·

吡咯替尼联合卡培他滨二线治疗HER-2阳性晚期乳腺癌的药物

经济学评价 Δ

王 琳 ，陈在余（中国药科大学国际医药商学院，南京 211198）
#
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中图分类号 R956；R737.9 文献标志码 A 文章编号 1001-0408（2022）13-1624-06
DOI 10.6039/j.issn.1001-0408.2022.13.15

摘 要 目的 从我国卫生体系角度出发，评价吡咯替尼联合卡培他滨二线治疗人表皮生长因子受体-2（HER-2）阳性晚期乳腺癌
的经济性，为临床治疗方案的选择及国家卫生决策提供参考。方法 基于一项在我国29个中心进行的多中心、开放标签、随机对照
的Ⅲ期临床试验构建动态Markov模型，模拟时限为8年，循环周期为21 d。比较吡咯替尼联合卡培他滨（观察组）与拉帕替尼联合
卡培他滨（对照组）二线治疗HER-2阳性晚期乳腺癌的经济性。以质量调整生命年（QALY）作为产出指标并计算增量成本-效果比
（ICER），再通过敏感性分析来验证基础分析结果的稳健性。结果 基础分析结果显示，观察组患者相对于对照组的人均增量成本
为67 953.82元，人均增量效用为0.40 QALYs，ICER为168 861.89元/QALY，低于以3倍2020年我国人均国内生产总值（GDP）作为
的意愿支付（WTP）阈值（217 500元/QALY），表明观察组治疗方案更具有经济性。单因素敏感性分析结果显示，对照组患者进入
疾病进展（PD）状态后使用曲妥珠单抗或吡咯替尼治疗比例、观察组患者进入PD状态后使用拉帕替尼或曲妥珠单抗治疗比例、卡
培他滨药物成本等参数对ICER影响较大，但这些参数均不能导致基础分析结果翻转。概率敏感性分析结果表明，当WTP阈值为
217 500元/QALY时，观察组治疗方案具有经济性的概率为94.10％。分区生存模型分析结果与动态Markov模型结果一致。结论
在以3倍2020年我国人均GDP为WTP阈值的前提下，吡咯替尼联合卡培他滨二线治疗HER-2阳性晚期乳腺癌较拉帕替尼联合
卡培他滨治疗方案更具有经济性。
关键词 吡咯替尼；拉帕替尼；卡培他滨；人表皮生长因子受体-2；晚期乳腺癌；药物经济学
Pharmacoeconomic evaluation of pyrotinib combined with capecitabine in the second-line treatment of
HER-2 positive patients with advanced breast cancer
WANG Lin，CHEN Zaiyu（School of International Pharmaceutical Business，China Pharmaceutical University，
Nanjing 211198，China）
ABSTRACT OBJECTIVE To evaluate the cost-effectiveness of pyrotinib combined with capecitabine in the second-line
treatment of human epidermal growth factor receptor-2（HER-2）positive advanced breast cancer from the point of view of medical
and health system，and to provide reference for the selection of clinical therapy plan and national health decision. METHODS The
dynamic Markov model was constructed on the basis of a multicenter，open，randomized controlled phase Ⅲ clinical trial in 29
centers in China. The simulation time limit was 8 years，and the cycle was 21 days. The cost-effectiveness of pyrotinib combined
with capecitabine （observation group） were compared with that of lapatinib combined with capecitabine （control group） in the
second-line treatment of HER-2 positive advanced breast cancer. The incremental cost-utility ratio（ICER）was calculated by using
quality-adjusted life year（QALY）as output indicators，and the sensitivity analysis was carried out to validate the robustness of the
results of basic analysis. RESULTS The results of basic analysis showed that compared with control group，the incremental cost
per capita and incremental utility per capita of observation group were 67 953.82 yuan and 0.40 QALYs；ICER was 168 861.89
yuan/QALY，which was lower than the willing to pay（WTP）threshold（217 500 yuan/QALY）represented by 3 times of China’s
per capita GDP in 2020，indicating the treatment plan of the observation group is more cost-effective. The results of single factor
sensitivity analysis showed that the proportion of patients treated with trastuzumab or pyrotinib after entering disease progression
（PD）status in the control group，the proportion of patients treated with lapatinib or trastuzumab after entering PD status in the
observation group，the cost of capecitabine and other parameters showed great impact on ICER，but those parameters didn’t cause
the reverse of basis analysis results. The results of probabilistic sensitivity analysis showed that when the WTP threshold was
217 500 yuan/QALY，the probability that the treatment plan in the observation group was cost-effective was 94.10％. The results of
partition survival model analysis were consistent with those of dynamic Markov model. CONCLUSIONS On the premise of taking
3 times of China’s per capita GDP in 2020 as the WTP
Δ 基金项目 国家自然科学基金资助项目（No.71874204）
＊第一作者 硕士研究生。研究方向：药物经济学。E-mail：lin- threshold， the second-line treatment of HER-2 positive
advanced breast cancer with pyrotinib combined with
wang9805@163.com
# 通信作者 副教授，硕士生导师，博士。研究方向：医疗保障、卫 capecitabine is more cost-effective than that with lapatinib
生经济学。E-mail：chenzaiy2002@163.com combined with capecitabine.

·1624 · China Pharmacy 2022 Vol. 33 No. 13 中国药房 2022年第33卷第13期